Home NDC 84440-003 Biocorneum
Product NDC 84440-003
11-digit product format 844400003
Labeler code 84440
Product ID 84440-003_2996022f-311c-4161-b6cc-1c746e9151d9
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Meradimate, Octisalate, and Octocrylene
Dosage form GEL
Route TOPICAL
Labeler Biodermis LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE
Active strength 30; 150; 50; 50; 100 mg/g; mg/g; mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Biocorneum
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/g HOMOSALATE 150 mg/g MERADIMATE 50 mg/g OCTISALATE 50 mg/g OCTOCRYLENE 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84440-003 BIOCORNEUM (AVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENE) GEL [BIODERMIS LLC] 1 Current NDC, 6 package rows 20240901_ef95f2b7-e438-4990-880d-81621edb2002.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 121 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 20 Zinc Oxide Non-Tinted Mineral Sunscreen ZINC OXIDE AGELESS SKINCARE INC 3766e6c0-8976-509d-e063-6394a90af00f 2025-12-15 Exact identifier application number: M020 20 Zinc Oxide Tinted Mineral Sunscreen ZINC OXIDE AGELESS SKINCARE INC 3766b00f-ceda-a6f9-e063-6294a90aff5d 2025-12-15 Exact identifier application number: M020 Mattifying Skin Primer TITANIUM DIOXIDE, ZINC OXIDE SKIN MAVEN 37662032-2842-1982-e063-6294a90a49a0 2025-12-15 Exact identifier application number: M020 Moisturizing Face and Body SPF ZINC OXIDE SKIN MAVEN 376645ee-7ea8-e738-e063-6394a90a119b 2025-12-15 Exact identifier application number: M020 Mermaid Glow And Go Non Tinted Mineral Sunscreen ZINC OXIDE Mermaid Glow LLC 3985a298-fe0b-c296-e063-6294a90ab6c0 2025-12-15 Exact identifier application number: M020 Mermaid Glow And Go Non Tinted Mineral Sunscreen ZINC OXIDE Mermaid Glow LLC 39856675-c110-a7a7-e063-6294a90ac6af 2025-12-15 Exact identifier application number: M020 Bio H Plus Daily Defense And Revitalize ZINC OXIDE BIOHEALTH PLUS LLC 3764f723-cc7a-2128-e063-6294a90ac894 2025-12-15 Exact identifier application number: M020 Extreme Protection Non Tinted ZINC OXIDE BIOHEALTH PLUS LLC 37656077-5185-817a-e063-6394a90adf5a 2025-12-15 Exact identifier application number: M020 Deluxe Lip Protection TITANIUM DIOXIDE, ZINC OXIDE BIOHEALTH PLUS LLC 37657895-5fec-82d0-e063-6294a90acf67 2025-12-15 Exact identifier application number: M020 Bio H Plus Daily Defense And Revitalize ZINC OXIDE BIOHEALTH PLUS LLC 3765331e-ad4b-5661-e063-6294a90a7c20 2025-12-15 Exact identifier application number: M020 Facial Mineral Fusion TITANIUM DIOXIDE, ZINC OXIDE IT INTELLIGENT TREATMENT LLC 35944621-e6fb-cd98-e063-6294a90aa641 2025-12-15 Exact identifier application number: M020 Face Love ZINC OXIDE CLARITY SKIN CARE STUDIO, INC. 35d043a7-7269-469f-e063-6294a90a1a4d 2025-12-15 Exact identifier application number: M020 Mineral Mousse TITANIUM DIOXIDE, ZINC OXIDE CLARITY SKIN CARE STUDIO, INC. 35d00778-3857-ce8f-e063-6394a90ab375 2025-12-15 Exact identifier application number: M020 Chem-Free Sunscreen Non-Tinted Formula ZINC OXIDE IT INTELLIGENT TREATMENT LLC 3594d573-c680-62c9-e063-6294a90a4229 2025-12-15 Exact identifier application number: M020 Chem Free Sunscreen Tinted Formula ZINC OXIDE IT INTELLIGENT TREATMENT LLC 35948531-37ef-1fce-e063-6294a90ae79b 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE R. Sonia Batra, MD, Inc. 35933039-8beb-9f98-e063-6394a90a60bb 2025-12-15 Exact identifier application number: M020 Simply Protected Tinted Mineral Sunscreen ZINC OXIDE Healthy Skin & Body LLC 380416b9-180a-3904-e063-6294a90a7bee 2025-12-15 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE R. Sonia Batra, MD, Inc. 3592edca-cab0-6c44-e063-6294a90a1727 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Healthy Skin & Body LLC 38046e71-f171-7e96-e063-6294a90a1f0b 2025-12-15 Exact identifier application number: M020 Barrier Plus Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Healthy Skin & Body LLC 38038beb-d0f0-ced2-e063-6294a90ac423 2025-12-15 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84440-003-10 84440000310 1 TUBE in 1 CARTON (84440-003-10) / 10 g in 1 TUBE 1 tube 2024-09-01 No No Current 84440-003-20 84440000320 1 TUBE in 1 CARTON (84440-003-20) / 20 g in 1 TUBE 1 tube 2024-09-01 No No Current 84440-003-50 84440000350 1 TUBE in 1 CARTON (84440-003-50) / 50 g in 1 TUBE 1 tube 2024-09-01 No No Current